Product profile · United States
PHYRAGO
· Patent Litigation & Settlement History ↓
Current GenericRadar decision
No verified direct-reference Final ANDA or unrestricted TrueDS/DS-equivalent/full-coverage exclusivity anchor is established for this exact product. Apply the approval-year DR fallback under the review policy. The available dasatinib ANDAs belong to the SPRYCEL reference family (NDA 021986). FDA letters for ANDAs 202103, 203180 and 211094 identify SPRYCEL. PHYRAGO is a separate NDA with gastric-acid interaction and formulation differences; no cross-NDA EG transfer.
Patent estate
| Patent | Effective date | Official listing | TRUE_DS | DS grade | Claim classification / basis | PTE | PED | Family |
|---|---|---|---|---|---|---|---|---|
| 11202778 | 2041-01-22 | U U-3771 | N | N | ACID_REDUCER_COADMINISTRATION_WITH_SPECIFIC_DISPERSION | — | — | — |
| 11202778 | 2041-01-22 | U U-3772 | N | N | ACID_REDUCER_COADMINISTRATION_WITH_SPECIFIC_DISPERSION | — | — | — |
| 11202778 | 2041-01-22 | U U-3770 | N | N | ACID_REDUCER_COADMINISTRATION_WITH_SPECIFIC_DISPERSION | — | — | — |
| 11202778 | 2041-01-22 | U U-3770 | N | N | ACID_REDUCER_COADMINISTRATION_WITH_SPECIFIC_DISPERSION Independent claims 1 and 7 require dasatinib in a specified methacrylic acid/ethyl acrylate amorphous solid dispersion, defined weight ratios, and coadministration with a gastric acid reducer. They do not cover treatment without the required coadministration. | — | — | — |
| 11202778 | 2041-01-22 | U U-3772 | N | N | ACID_REDUCER_COADMINISTRATION_WITH_SPECIFIC_DISPERSION Independent claims 1 and 7 require dasatinib in a specified methacrylic acid/ethyl acrylate amorphous solid dispersion, defined weight ratios, and coadministration with a gastric acid reducer. They do not cover treatment without the required coadministration. | — | — | — |
| 11202778 | 2041-01-22 | U U-3771 | N | N | ACID_REDUCER_COADMINISTRATION_WITH_SPECIFIC_DISPERSION Independent claims 1 and 7 require dasatinib in a specified methacrylic acid/ethyl acrylate amorphous solid dispersion, defined weight ratios, and coadministration with a gastric acid reducer. They do not cover treatment without the required coadministration. | — | — | — |
| 11298356 | 2041-01-22 | DP — | N | N | AMORPHOUS_SOLID_DISPERSION | — | — | — |
| 11298356 | 2041-01-22 | DP — | N | N | AMORPHOUS_SOLID_DISPERSION Independent composition and kit claims require dasatinib and a pH-dependent methacrylic acid/ethyl acrylate copolymer in an amorphous solid dispersion at a 30:70 to 95:5 weight ratio. This is formulation protection, not the dasatinib molecule. | — | — | — |
| 11324745 | 2041-01-22 | U U-3768 | N | N | PROLIFERATIVE_DISORDER_TREATMENT_WITH_SPECIFIC_DISPERSION | — | — | — |
| 11324745 | 2041-01-22 | U U-3769 | N | N | PROLIFERATIVE_DISORDER_TREATMENT_WITH_SPECIFIC_DISPERSION | — | — | — |
| 11324745 | 2041-01-22 | U U-3767 | N | N | PROLIFERATIVE_DISORDER_TREATMENT_WITH_SPECIFIC_DISPERSION | — | — | — |
| 11324745 | 2041-01-22 | U U-3768 | N | N | PROLIFERATIVE_DISORDER_TREATMENT_WITH_SPECIFIC_DISPERSION Independent treatment claims require dasatinib in a specified amorphous solid dispersion with polymer and weight-ratio limitations; claims 1, 17 and 29 expressly restrict gastric pH, while claim 28 addresses administration without regard to elevated gastric pH. The formulation limitations prevent unrestricted full-label equivalence. | — | — | — |
| 11324745 | 2041-01-22 | U U-3769 | N | N | PROLIFERATIVE_DISORDER_TREATMENT_WITH_SPECIFIC_DISPERSION Independent treatment claims require dasatinib in a specified amorphous solid dispersion with polymer and weight-ratio limitations; claims 1, 17 and 29 expressly restrict gastric pH, while claim 28 addresses administration without regard to elevated gastric pH. The formulation limitations prevent unrestricted full-label equivalence. | — | — | — |
| 11324745 | 2041-01-22 | U U-3767 | N | N | PROLIFERATIVE_DISORDER_TREATMENT_WITH_SPECIFIC_DISPERSION Independent treatment claims require dasatinib in a specified amorphous solid dispersion with polymer and weight-ratio limitations; claims 1, 17 and 29 expressly restrict gastric pH, while claim 28 addresses administration without regard to elevated gastric pH. The formulation limitations prevent unrestricted full-label equivalence. | — | — | — |
| 12433891 | 2041-01-22 | U U-3772 | N | N | LEUKEMIA_TREATMENT_WITH_SPECIFIC_DISPERSION | — | — | — |
| 12433891 | 2041-01-22 | U U-3770 | N | N | LEUKEMIA_TREATMENT_WITH_SPECIFIC_DISPERSION | — | — | — |
| 12433891 | 2041-01-22 | U U-3771 | N | N | LEUKEMIA_TREATMENT_WITH_SPECIFIC_DISPERSION | — | — | — |
| 12433891 | 2041-01-22 | U U-3768 | N | N | LEUKEMIA_TREATMENT_WITH_SPECIFIC_DISPERSION | — | — | — |
| 12433891 | 2041-01-22 | U U-3767 | N | N | LEUKEMIA_TREATMENT_WITH_SPECIFIC_DISPERSION | — | — | — |
| 12433891 | 2041-01-22 | U U-3769 | N | N | LEUKEMIA_TREATMENT_WITH_SPECIFIC_DISPERSION | — | — | — |
| 12433891 | 2041-01-22 | U U-3769 | N | N | LEUKEMIA_TREATMENT_WITH_SPECIFIC_DISPERSION Independent treatment claims require leukemia treatment using a dasatinib/copolymer amorphous solid dispersion with a specified weight ratio; claim 1 additionally requires an H2 antagonist or proton-pump inhibitor. The formulation limitations remain material. | — | — | — |
| 12433891 | 2041-01-22 | U U-3770 | N | N | LEUKEMIA_TREATMENT_WITH_SPECIFIC_DISPERSION Independent treatment claims require leukemia treatment using a dasatinib/copolymer amorphous solid dispersion with a specified weight ratio; claim 1 additionally requires an H2 antagonist or proton-pump inhibitor. The formulation limitations remain material. | — | — | — |
| 12433891 | 2041-01-22 | U U-3772 | N | N | LEUKEMIA_TREATMENT_WITH_SPECIFIC_DISPERSION Independent treatment claims require leukemia treatment using a dasatinib/copolymer amorphous solid dispersion with a specified weight ratio; claim 1 additionally requires an H2 antagonist or proton-pump inhibitor. The formulation limitations remain material. | — | — | — |
| 12433891 | 2041-01-22 | U U-3771 | N | N | LEUKEMIA_TREATMENT_WITH_SPECIFIC_DISPERSION Independent treatment claims require leukemia treatment using a dasatinib/copolymer amorphous solid dispersion with a specified weight ratio; claim 1 additionally requires an H2 antagonist or proton-pump inhibitor. The formulation limitations remain material. | — | — | — |
| 12433891 | 2041-01-22 | U U-3767 | N | N | LEUKEMIA_TREATMENT_WITH_SPECIFIC_DISPERSION Independent treatment claims require leukemia treatment using a dasatinib/copolymer amorphous solid dispersion with a specified weight ratio; claim 1 additionally requires an H2 antagonist or proton-pump inhibitor. The formulation limitations remain material. | — | — | — |
| 12433891 | 2041-01-22 | U U-3768 | N | N | LEUKEMIA_TREATMENT_WITH_SPECIFIC_DISPERSION Independent treatment claims require leukemia treatment using a dasatinib/copolymer amorphous solid dispersion with a specified weight ratio; claim 1 additionally requires an H2 antagonist or proton-pump inhibitor. The formulation limitations remain material. | — | — | — |
| 12465606 | 2041-01-22 | DP — | N | N | AMORPHOUS_SOLID_DISPERSION | — | — | — |
| 12465606 | 2041-01-22 | DP — | N | N | AMORPHOUS_SOLID_DISPERSION Independent composition claims require an amorphous solid dispersion containing dasatinib and a pH-dependent methacrylic acid/ethyl acrylate copolymer at a defined weight ratio. They do not claim all compositions containing dasatinib. | — | — | — |
| 12544376 | 2041-01-22 | U U-3767 | N | N | ELEVATED_GASTRIC_PH_TREATMENT_REGIMEN | — | — | — |
| 12544376 | 2041-01-22 | U U-3771 | N | N | ELEVATED_GASTRIC_PH_TREATMENT_REGIMEN | — | — | — |
| 12544376 | 2041-01-22 | U U-3768 | N | N | ELEVATED_GASTRIC_PH_TREATMENT_REGIMEN | — | — | — |
| 12544376 | 2041-01-22 | U U-3769 | N | N | ELEVATED_GASTRIC_PH_TREATMENT_REGIMEN | — | — | — |
| 12544376 | 2041-01-22 | U U-3770 | N | N | ELEVATED_GASTRIC_PH_TREATMENT_REGIMEN | — | — | — |
| 12544376 | 2041-01-22 | U U-3772 | N | N | ELEVATED_GASTRIC_PH_TREATMENT_REGIMEN | — | — | — |
| 12544376 | 2041-01-22 | U U-3771 | N | N | ELEVATED_GASTRIC_PH_TREATMENT_REGIMEN Independent regimen claims require a proton-pump inhibitor or H2 antagonist, gastric pH greater than 4, a specified dasatinib/copolymer dispersion and ratio, and exposure-related conditions. They do not cover every approved treatment setting. | — | — | — |
| 12544376 | 2041-01-22 | U U-3772 | N | N | ELEVATED_GASTRIC_PH_TREATMENT_REGIMEN Independent regimen claims require a proton-pump inhibitor or H2 antagonist, gastric pH greater than 4, a specified dasatinib/copolymer dispersion and ratio, and exposure-related conditions. They do not cover every approved treatment setting. | — | — | — |
| 12544376 | 2041-01-22 | U U-3768 | N | N | ELEVATED_GASTRIC_PH_TREATMENT_REGIMEN Independent regimen claims require a proton-pump inhibitor or H2 antagonist, gastric pH greater than 4, a specified dasatinib/copolymer dispersion and ratio, and exposure-related conditions. They do not cover every approved treatment setting. | — | — | — |
| 12544376 | 2041-01-22 | U U-3769 | N | N | ELEVATED_GASTRIC_PH_TREATMENT_REGIMEN Independent regimen claims require a proton-pump inhibitor or H2 antagonist, gastric pH greater than 4, a specified dasatinib/copolymer dispersion and ratio, and exposure-related conditions. They do not cover every approved treatment setting. | — | — | — |
| 12544376 | 2041-01-22 | U U-3770 | N | N | ELEVATED_GASTRIC_PH_TREATMENT_REGIMEN Independent regimen claims require a proton-pump inhibitor or H2 antagonist, gastric pH greater than 4, a specified dasatinib/copolymer dispersion and ratio, and exposure-related conditions. They do not cover every approved treatment setting. | — | — | — |
| 12544376 | 2041-01-22 | U U-3767 | N | N | ELEVATED_GASTRIC_PH_TREATMENT_REGIMEN Independent regimen claims require a proton-pump inhibitor or H2 antagonist, gastric pH greater than 4, a specified dasatinib/copolymer dispersion and ratio, and exposure-related conditions. They do not cover every approved treatment setting. | — | — | — |
Regulatory exclusivity
| Code | Start date | End date | Scope | Entire product | All indications | Full coverage date | Combination | Source |
|---|---|---|---|---|---|---|---|---|
| M-307 | 2023-12-05 | 2026-12-05 | Information added to clinical pharmacology describing a gastric acid-reducing agent interaction study. | N | N | — | Source | |
| M-307 | 2023-12-05 | 2026-12-05 | Information added to clinical pharmacology describing a gastric acid-reducing agent interaction study. | N | N | — | Source |
2026-10-11 · CURRENT_SNAPSHOT_RECORDS · Historical coverage: NOT_COMPLETE
2026-10-10 · CURRENT_SOURCE_RECORDS_FOUND · Historical coverage: NOT_COMPLETE
Generic approval evidence
| Application / product | Event | Final date | Tentative date | Applicant | Authorized generic | Exact mapping | Source |
|---|---|---|---|---|---|---|---|
| 219579 / 006 | APPLICATION_FINAL_OBSERVATION · FINAL_PRODUCT_DATE_UNVERIFIED | — | — | MSN | N | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source |
| 203180 / 002 | FINAL_APPROVAL · FINAL_APPROVED | 2021-11-23 | — | APOTEX INC | N | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source |
| 213383 / 006 | FINAL_APPROVAL · FINAL_APPROVED | 2025-03-03 | — | DR REDDYS LABORATORIES LTD | N | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source |
| 217217 / 006 | FINAL_APPROVAL · FINAL_APPROVED | 2025-03-03 | — | BIOCON PHARMA LTD | N | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source |
| 218719 / 006 | FINAL_APPROVAL · FINAL_APPROVED | 2025-03-03 | — | ZYDUS PHARMACEUTICALS USA INC | N | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source |
| 216547 / 006 | FINAL_APPROVAL · FINAL_APPROVED | 2025-04-22 | — | EUGIA PHARMA SPECIALITIES LTD | N | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source |
| 214350 / 006 | FINAL_APPROVAL · FINAL_APPROVED | 2025-08-25 | — | LUPIN INC | N | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source |
| 211094 / 006 | FINAL_APPROVAL · FINAL_APPROVED | 2025-08-27 | — | TEVA PHARMACEUTICALS USA INC | N | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source |
| 216261 / 006 | FINAL_APPROVAL · FINAL_APPROVED | 2025-11-06 | — | ALEMBIC PHARMACEUTICALS LTD | N | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source |
Market Entry Information
API filings, authorized generics and linked regulatory milestones.
API Master Files & Certifications 0 records
Ingredient-level registrations from linked public manufacturer portfolios. A filing does not establish supply to this finished product. DMFs are not FDA approvals.
| API | Holder / manufacturer | Holder country | Filing type | Number | Status | Filed date | Available for reference | Source | Last verified |
|---|---|---|---|---|---|---|---|---|---|
| No master-file or certification records are linked through public manufacturer portfolios. | |||||||||
Authorized Generics 0 records
Authorized generics are shown separately from independent ANDA approvals.
| Application / product | Applicant | Event / status | First marketed | Product mapping | Source | Last verified |
|---|---|---|---|---|---|---|
| No authorized-generic records are linked to this product. | ||||||
Tentative ANDA Approvals 0 records
Tentative approval is not final approval. Historical tentative approvals remain visible after a linked final approval.
| Application / product | Applicant | Event / status | Tentative date | Follow-up final approval | Product mapping | Source | Last verified |
|---|---|---|---|---|---|---|---|
| No tentative-approval records are linked to this product. | |||||||
Paragraph IV Challenges 0 records
Paragraph IV challenges below are sourced from legal records separately from FDA approvals. An ANDA filing, lawsuit or settlement does not establish final approval or commercial launch.
| Application / product | Applicant | Event / status | Certification event date | Product mapping | Source | Last verified |
|---|---|---|---|---|---|---|
| No structured Paragraph IV certification events are linked in the available approval evidence. | ||||||
Final ANDA Approvals 8 records
Approval dates do not establish commercial launch. Product mapping is shown for each linked record.
| Application / product | Applicant | Event / status | Final approval date | Product mapping | Source | Last verified |
|---|---|---|---|---|---|---|
| 203180 / 002 | APOTEX INC | FINAL_APPROVAL · FINAL_APPROVED | 2021-11-23 | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source | — |
| 213383 / 006 | DR REDDYS LABORATORIES LTD | FINAL_APPROVAL · FINAL_APPROVED | 2025-03-03 | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source | — |
| 217217 / 006 | BIOCON PHARMA LTD | FINAL_APPROVAL · FINAL_APPROVED | 2025-03-03 | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source | — |
| 218719 / 006 | ZYDUS PHARMACEUTICALS USA INC | FINAL_APPROVAL · FINAL_APPROVED | 2025-03-03 | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source | — |
| 216547 / 006 | EUGIA PHARMA SPECIALITIES LTD | FINAL_APPROVAL · FINAL_APPROVED | 2025-04-22 | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source | — |
| 214350 / 006 | LUPIN INC | FINAL_APPROVAL · FINAL_APPROVED | 2025-08-25 | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source | — |
| 211094 / 006 | TEVA PHARMACEUTICALS USA INC | FINAL_APPROVAL · FINAL_APPROVED | 2025-08-27 | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source | — |
| 216261 / 006 | ALEMBIC PHARMACEUTICALS LTD | FINAL_APPROVAL · FINAL_APPROVED | 2025-11-06 | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source | — |
Decision evidence (22)
| Type | Date | Role | Basis | Source |
|---|---|---|---|---|
| PATENT | 2041-01-22 | FTO_TAIL | Independent treatment claims require dasatinib in a specified amorphous solid dispersion with polymer and weight-ratio limitations; claims 1, 17 and 29 expressly restrict gastric pH, while claim 28 addresses administration without regard to elevated gastric pH. The formulation limitations prevent unrestricted full-label equivalence. | Source |
| PATENT | 2041-01-22 | FTO_TAIL | Independent regimen claims require a proton-pump inhibitor or H2 antagonist, gastric pH greater than 4, a specified dasatinib/copolymer dispersion and ratio, and exposure-related conditions. They do not cover every approved treatment setting. | Source |
| PATENT | 2041-01-22 | FTO_TAIL | Independent composition claims require an amorphous solid dispersion containing dasatinib and a pH-dependent methacrylic acid/ethyl acrylate copolymer at a defined weight ratio. They do not claim all compositions containing dasatinib. | Source |
| PATENT | 2041-01-22 | FTO_TAIL | Independent composition and kit claims require dasatinib and a pH-dependent methacrylic acid/ethyl acrylate copolymer in an amorphous solid dispersion at a 30:70 to 95:5 weight ratio. This is formulation protection, not the dasatinib molecule. | Source |
| PATENT | 2041-01-22 | FTO_TAIL | Independent regimen claims require a proton-pump inhibitor or H2 antagonist, gastric pH greater than 4, a specified dasatinib/copolymer dispersion and ratio, and exposure-related conditions. They do not cover every approved treatment setting. | Source |
| PATENT | 2041-01-22 | FTO_TAIL | Independent treatment claims require dasatinib in a specified amorphous solid dispersion with polymer and weight-ratio limitations; claims 1, 17 and 29 expressly restrict gastric pH, while claim 28 addresses administration without regard to elevated gastric pH. The formulation limitations prevent unrestricted full-label equivalence. | Source |
| PATENT | 2041-01-22 | FTO_TAIL | Independent treatment claims require leukemia treatment using a dasatinib/copolymer amorphous solid dispersion with a specified weight ratio; claim 1 additionally requires an H2 antagonist or proton-pump inhibitor. The formulation limitations remain material. | Source |
| PATENT | 2041-01-22 | FTO_TAIL | Independent treatment claims require leukemia treatment using a dasatinib/copolymer amorphous solid dispersion with a specified weight ratio; claim 1 additionally requires an H2 antagonist or proton-pump inhibitor. The formulation limitations remain material. | Source |
| PATENT | 2041-01-22 | FTO_TAIL | Independent claims 1 and 7 require dasatinib in a specified methacrylic acid/ethyl acrylate amorphous solid dispersion, defined weight ratios, and coadministration with a gastric acid reducer. They do not cover treatment without the required coadministration. | Source |
| PATENT | 2041-01-22 | FTO_TAIL | Independent treatment claims require leukemia treatment using a dasatinib/copolymer amorphous solid dispersion with a specified weight ratio; claim 1 additionally requires an H2 antagonist or proton-pump inhibitor. The formulation limitations remain material. | Source |
| PATENT | 2041-01-22 | FTO_TAIL | Independent claims 1 and 7 require dasatinib in a specified methacrylic acid/ethyl acrylate amorphous solid dispersion, defined weight ratios, and coadministration with a gastric acid reducer. They do not cover treatment without the required coadministration. | Source |
| PATENT | 2041-01-22 | FTO_TAIL | Independent treatment claims require leukemia treatment using a dasatinib/copolymer amorphous solid dispersion with a specified weight ratio; claim 1 additionally requires an H2 antagonist or proton-pump inhibitor. The formulation limitations remain material. | Source |
| PATENT | 2041-01-22 | FTO_TAIL | Independent treatment claims require leukemia treatment using a dasatinib/copolymer amorphous solid dispersion with a specified weight ratio; claim 1 additionally requires an H2 antagonist or proton-pump inhibitor. The formulation limitations remain material. | Source |
| PATENT | 2041-01-22 | FTO_TAIL | Independent regimen claims require a proton-pump inhibitor or H2 antagonist, gastric pH greater than 4, a specified dasatinib/copolymer dispersion and ratio, and exposure-related conditions. They do not cover every approved treatment setting. | Source |
| PATENT | 2041-01-22 | FTO_TAIL | Independent treatment claims require dasatinib in a specified amorphous solid dispersion with polymer and weight-ratio limitations; claims 1, 17 and 29 expressly restrict gastric pH, while claim 28 addresses administration without regard to elevated gastric pH. The formulation limitations prevent unrestricted full-label equivalence. | Source |
| PATENT | 2041-01-22 | FTO_TAIL | Independent treatment claims require leukemia treatment using a dasatinib/copolymer amorphous solid dispersion with a specified weight ratio; claim 1 additionally requires an H2 antagonist or proton-pump inhibitor. The formulation limitations remain material. | Source |
| PATENT | 2041-01-22 | FTO_TAIL | Independent regimen claims require a proton-pump inhibitor or H2 antagonist, gastric pH greater than 4, a specified dasatinib/copolymer dispersion and ratio, and exposure-related conditions. They do not cover every approved treatment setting. | Source |
| PATENT | 2041-01-22 | FTO_TAIL | Independent regimen claims require a proton-pump inhibitor or H2 antagonist, gastric pH greater than 4, a specified dasatinib/copolymer dispersion and ratio, and exposure-related conditions. They do not cover every approved treatment setting. | Source |
| PATENT | 2041-01-22 | FTO_TAIL | Independent claims 1 and 7 require dasatinib in a specified methacrylic acid/ethyl acrylate amorphous solid dispersion, defined weight ratios, and coadministration with a gastric acid reducer. They do not cover treatment without the required coadministration. | Source |
| PATENT | 2041-01-22 | FTO_TAIL | Independent regimen claims require a proton-pump inhibitor or H2 antagonist, gastric pH greater than 4, a specified dasatinib/copolymer dispersion and ratio, and exposure-related conditions. They do not cover every approved treatment setting. | Source |
| REGULATORY_EXCLUSIVITY | — | SCOPE_CONTEXT | Information added to clinical pharmacology describing a gastric acid-reducing agent interaction study. | Source |
| REGULATORY_STATUS | 2023-12-05 | DECISION_BASIS | No verified direct-reference Final ANDA or unrestricted TrueDS/DS-equivalent/full-coverage exclusivity anchor is established for this exact product. Apply the approval-year DR fallback under the review policy. The available dasatinib ANDAs belong to the SPRYCEL reference family (NDA 021986). FDA letters for ANDAs 202103, 203180 and 211094 identify SPRYCEL. PHYRAGO is a separate NDA with gastric-acid interaction and formulation differences; no cross-NDA EG transfer. | Source |
Independent legal-event information
Litigation & Settlement History
Settlement launch rights generally apply only to the named parties and product scope. These records do not change GenericRadar patent/exclusivity anchors or current decisions.
No litigation or settlement record currently linked to this product.